Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT01837394
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2013-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D009020', 'term': 'Morphine'}, {'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D008787', 'term': 'Metoclopramide'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2013-04-15', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain on knee flexion', 'timeFrame': '24 hours postoperatively', 'description': 'VRS (Verbal Rating Scale) score 0-10 on active flexion of the knee to 45 degrees, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis.'}], 'secondaryOutcomes': [{'measure': 'Pain at rest', 'timeFrame': '24 hours postoperatively', 'description': 'VRS (verbal rating score) 0-10 at rest, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis.'}, {'measure': 'Time to opioid intake', 'timeFrame': '24 hours postoperatively', 'description': 'First time the patient needs to take supplementary opioids in the postoperative period'}, {'measure': 'Total opioid intake', 'timeFrame': '24 hours', 'description': 'Total dose of opioids taken in the first 24 hours postoperatively'}, {'measure': 'Nausea', 'timeFrame': '24 hours postoperatively', 'description': 'VRS score 0-10, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis.'}, {'measure': 'Vomiting', 'timeFrame': '24 hours', 'description': 'Number of times the patient has vomited in the first 24 hours postoperatively.'}, {'measure': 'Use of antiemetics', 'timeFrame': '24 hours', 'description': 'Total dose of antiemetics taken during the first 24 hours postoperatively'}, {'measure': 'PACU length of stay', 'timeFrame': '24 hours', 'description': 'Total length of stay in the post anesthetic care unit (PACU) after the operation.'}, {'measure': 'Function level: Barthel Index/100', 'timeFrame': '24 hours', 'description': 'Modified Barthel Index/100 score 24 hours after the operation.'}, {'measure': 'Function level: Short form (SF) -8', 'timeFrame': '24 hours', 'description': 'Short form (SF) -8 questionnaire 24 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nerve block', 'Ultrasound', 'postoperative pain', 'Saphenous nerve', 'Obturator nerve'], 'conditions': ['Postoperative Pain', 'Postoperative Nausea and Vomiting', 'Postoperative Function Level']}, 'descriptionModule': {'briefSummary': 'In this study, we wish to investigate the effect of ultrasound (US) -guided block of the saphenous nerve (SN) and the posterior branch of the obturator nerve (ONP) on postoperative pain and the use of opioids (morphine-like pain medicine) in the first 24 hours following ambulatory knee arthroscopy.\n\nWe wish to investigate the analgesic effect of these two blocks compared to placebo (injection of local anesthetic with known pain blocking properties compared with injection of a saline solution), when used as a supplement to conventional oral analgesics.\n\nWe hypothesize that patients receiving the active treatment may experience less pain during the first 24 hours after their operation than patients receiving the placebo treatment, and possibly require less opioid analgesics, experience less opioid related side effects and have a higher function level in this period than patients receiving the placebo treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned ambulatory knee arthroscopy, except cruciate ligament surgery\n* American Society of Anesthesiologists (ASA) class 1-3\n\nExclusion Criteria:\n\n* Cannot cooperate\n* Do not speak or understand Danish\n* Daily use of opioid analgesics\n* Allergy towards any of the drugs used in the investigation\n* Medicine abuse (at the investigators discretion)\n* Alcohol abuse, as defined by the National Board of Health\n* General anesthesia contraindicated, or the patient wants spinal anesthesia\n* Visualization of necessary structures by ultrasound not possible, or block not possible for other technical reasons'}, 'identificationModule': {'nctId': 'NCT01837394', 'briefTitle': 'Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Ultrasound-guided Block of the Saphenous Nerve and Obturator Nerve, Posterior Branch, for Postoperative Pain Management After Ambulatory Knee Arthroscopy', 'orgStudyIdInfo': {'id': 'H-2-2011-029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Block arm', 'description': 'Ultrasound guided block of the SN and ONP with 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.', 'interventionNames': ['Procedure: Block of the SN and ONP', 'Drug: Paracetamol', 'Drug: Morphine', 'Drug: Ondansetron', 'Drug: Metoclopramide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Ultrasound guided placebo block of the SN and ONP with 7.5 ml of isotonic saline solution injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.', 'interventionNames': ['Procedure: Placebo block', 'Drug: Paracetamol', 'Drug: Morphine', 'Drug: Ondansetron', 'Drug: Metoclopramide']}], 'interventions': [{'name': 'Block of the SN and ONP', 'type': 'PROCEDURE', 'otherNames': ['Naropin'], 'description': '7.5 ml of Ropivacaine 7.5 mg/ml injected at each site', 'armGroupLabels': ['Block arm']}, {'name': 'Placebo block', 'type': 'PROCEDURE', 'otherNames': ['NaCl'], 'description': '7.5 ml of isotonic saline solution 154 mmol/l injected at each site', 'armGroupLabels': ['Placebo arm']}, {'name': 'Paracetamol', 'type': 'DRUG', 'otherNames': ['Acetaminophen'], 'armGroupLabels': ['Block arm', 'Placebo arm']}, {'name': 'Morphine', 'type': 'DRUG', 'description': '5 mg as needed', 'armGroupLabels': ['Block arm', 'Placebo arm']}, {'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Zofran'], 'description': '4 mg i.v. as needed in the PACU', 'armGroupLabels': ['Block arm', 'Placebo arm']}, {'name': 'Metoclopramide', 'type': 'DRUG', 'otherNames': ['Emperal', 'Primperan'], 'description': '10 mg tablet as needed in the postoperative period after discharge from the PACU', 'armGroupLabels': ['Block arm', 'Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Anesthesiology, Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Bo Westergaard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Bispebjerg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Borglum Neimann', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, MBA', 'investigatorFullName': 'Jens Borglum Neimann', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}